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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Houchin Blood Services Warning Letter Response

Response to Houchin Blood Services Warning Letter dated September 21, 2005

The responses to Warning Letter will be in bold italics for ease of reference. Your facility failed to follow the manufacturer's instructions. when performing confirmatory tests on blood and blood components. [21 CFR 606.65 (e)].

Specifically, your facility has a contract with another blood bank to perform testing. This contracted blood bank in turn has a contract with another laboratory for testing of HIV Western Blot and HTLV confirmatory tests. This laboratory utilizes the [redacted] HIV-1 Western Blot assay, for which the instructions for use states, that the serum or plasma may be stored up to [redacted] at [redacted]. The storage conditions during storage and transit of the blood samples cannot be determined. For example, a blood sample [redacted] from Donor [redacted] was drawn on [redacted]. The date the sample was receive at the contract laboratory was [redacted]. A final report was processed on [redacted]. This time frame exceeds the seven day storage period. There [redacted] is no documentation of the exact conditions at which samples are maintained, and the specimens are not maintained frozen. The manufacturer's instructions are not followed, test results are accepted and donors are re-entered [redacted] based on these test results.

Routine audits of the testing, laboratory will be conducted to ensure that the manufacturer's instructions for storage temperature of the samples are followed. In addition, we will determine that all samples have been tested according to the time line required by the manufacturer. The samples for confirmatory testing are now frozen prior to transport to the testing laboratory. The temperature of the samples will be monitored to ensure compliance to the range stated in the manufacturer's instructions.

The donor re-entry program is indefinitely suspended. No donor will be re-entered until audits reveal compliance with the storage temperatures as required by the manufacturer as stated in the manufacturer's instructions for use of the test.

Tests on donor samples that did not comply with the required storage temperatures and the time line will be repeated to ensure the original test results are valid Donors will be indefinitely deferred if they do not return for testing as requested All donors that are not deemed suitable after following the FDA approved algorithm will be permanently deferred. Staff members of our QA department will perform vendor audits of the [redacted] testing laboratory to ensure that the testing laboratory adheres to the timelines in the manufacturer's instructions ruse of the test kits. An audit of the testing laboratory is scheduled to be performed on [redacted].

Procedures have been revised to reflect these changes.

2. a) Your facility failed to take appropriate action when a donor tests repeatedly reactive for antibody to human immunodeficiency virus (HIV) as required by "Lookback" requirements [21 CFR 610.46(a)(1)]. Specifically,

i). Consignees are not notified with 72 hours of a repeat reactive HIV result for purposes of quarantine.
ii) Consignees are not notified of all products, only in-date products;
iii) A twelve month lookback is performed from the repeat reactive test result instead of the last non-reactive test-result

For examples; Donor [redacted] tested HIV repeat reactive on [redacted]
The donor's prior lookback donations include:
Unit [redacted] donated on [redacted] which consisted of a RBC unit
Unit [redacted] donated on [redacted] which consisted of a RBC unit
Unit [redacted] donated on [redacted] which consisted of a washed cell

Lookback notification for unit [redacted] did not occur until [redacted] not initiated for units [redacted] and [redacted]

b) Your facility lacks written procedures in accordance with 21 CFR 610.46 to took at prior donations of Whole Blood, blood components, Source Plasma, and Source Leukocytes, when a donor of blood subsequently tests repeatedly reactive for antibody to HIV, or otherwise is determined to be unsuitable when tested in accordance with the applicable regulations [21 CFR 606.100(b)(19)].

Specifically our facility Standard Operation Procedure (SOP) [redacted] is not consistent with regulations in that your SOP states:

i) Quarantine and destruction is performed for in-date components only;
ii) The recovered plasma contractor is to be notified within [redacted] instead of 72 hours
iii) Within [redacted] of notification of a positive confirmatory test interpretation, identify and arrange for quarantine and discard of all in-date components, performance of quarantine and discard extends back [redacted] prior to the donor's last negative test result

a) Procedures have been revised and training on the procedures was given to ensure compliance with 21 CFR 610.46(a)(1).

i) Consignees are notified within 72 hours following receipt .of a repeat reactive test result for HIV. Donor records are reviewed to determine, the date of the last non-reactive test result. Consignees are notified of the date of the last non-reactive test result.

ii) Procedures have been changed to reflect that consignees will be notified of all products involved in the lookback as required by regulation.

iii) The procedure for the timeline required by regulation has been changed to state that lookback is performed for five years or 12 months prior to the last negative test result.

b) The procedures have been, revised to state that prior donations for all products will be included in the lookback process.

3. Your facility failed to maintain written standard operating procedures describing the criteria used to determine donor suitability, including acceptable medical history criteria [ 21 CFR 606.100(b)(I)]. Specifically, there are no specific procedures established for the re-entry protocols for donors who have tested repeat reactive for HIV 1/2, HCV, HBsAg and HBc.

All re-entry of donors with a repeatedly reactive viral marker test has been suspended for the present. Procedures for re-entry have been created and will follow the algorithms found in Center for Biologics Evaluation and Research (CBER) guidance documents. The procedures will be submitted to CBER for approval. Prior to implementation of the protocols for re-entry, we will train the staff on the approved procedures. The procedures will provide for sign of by, [redacted] trained individuals prior to donor re-entry. The process will be closely monitored to ensure that only suitable donors are re-entered. The internal audit program will be enhanced to ensure compliance with FDA algorithms for donor re-entry.

4. Your facility failed to make reasonable attempts to notify the donor within 8 weeks after determining that the donor is deferred or determined not to be suitable for donation [21 CFR 630.6(c)]. For example, donor [redacted] tested repeat reactive for HIV on [redacted] Western blot negative on [redacted]The first notification occurred on [redacted] the second notification occurred on [redacted] and the third notification occurred on [redacted]; which is approximately 14 weeks after confirmatory test results. Also noted during the inspection was that your facility failed to document that you had successfully notified this deferred donor.

The procedure has been revised to reflect the intent of the regulation. We will ensure that the notification of the donor will be performed within the 8 week timeline in 21 CFR 630.6(c).

Staff will. be trained on the revised procedure and QA staff will perform audits to ensure compliance with the regulation.